NDC 50458-536

Terazol 3

Terconazole

Terazol 3 is a Vaginal Cream in the Human Prescription Drug category. It is labeled and distributed by Janssen Pharmaceuticals, Inc.. The primary component is Terconazole.

Product ID50458-536_9a055cd8-638b-11ea-a644-412efc2ca371
NDC50458-536
Product TypeHuman Prescription Drug
Proprietary NameTerazol 3
Generic NameTerconazole
Dosage FormCream
Route of AdministrationVAGINAL
Marketing Start Date1991-02-21
Marketing End Date2020-06-15
Marketing CategoryNDA /
Application NumberNDA019964
Labeler NameJanssen Pharmaceuticals, Inc.
Substance NameTERCONAZOLE
Active Ingredient Strength8 mg/g
Pharm ClassesAzole Antifungal [EPC],Azoles [CS]
NDC Exclude FlagN

Packaging

NDC SPL Data Element Entries

NDC 50458-536-01 [50458053601]

Terazol 3 CREAM
Marketing CategoryNDA
Application NumberNDA019964
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date1991-02-21
Marketing End Date2016-10-31

Drug Details

NDC Crossover Matching brand name "Terazol 3" or generic name "Terconazole"

NDCBrand NameGeneric Name
50458-531Terazol 3TERCONAZOLE
50458-536Terazol 3TERCONAZOLE
50458-535Terazol 7TERCONAZOLE
0168-0346Terconazoleterconazole
0168-0347Terconazoleterconazole
0591-3196TERCONAZOLETERCONAZOLE
0591-3197TERCONAZOLETERCONAZOLE
0713-0552TerconazoleTerconazole
21695-844TerconazoleTerconazole
21695-933TERCONAZOLEterconazole
45802-717TerconazoleTerconazole
50090-0917TerconazoleTerconazole
50090-1196TerconazoleTerconazole
50090-2341TERCONAZOLETERCONAZOLE
50090-6266Terconazoleterconazole
51672-1302TerconazoleTerconazole
51672-1304TerconazoleTerconazole
51672-1330TerconazoleTerconazole
52959-811TERCONAZOLEterconazole
53002-7240TerconazoleTerconazole
53002-8130TerconazoleTerconazole
55045-3259TERCONAZOLEterconazole
63629-8837Terconazoleterconazole
68071-1626TerconazoleTerconazole
70518-1185TerconazoleTerconazole
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